Hi friends!!!
In our previous blog we had a introduction about Medical Device Single Audit Program, MDSAP Audit Cycle, Management process Audit, Device marketing authorization and facility registration, MDSAP Measurement, Analysis and Improvement Process. Please check out for the link below.
Medical Device Single Audit Program - Part 1
MDSAP Audit Cycle - Part 2
MDSAP Management Process Audit - Part 3
MDSAP Management Process Audit - Part 4
MDSAP Device Marketing Authorization and Facility Registration - Part 5
MDSAP Measurement, Analysis and Improvement - Part 6
MDSAP Measurement, Analysis and Improvement - Part 7
In today's blog we will discuss in detail about Medical Device Single Audit Program (MDSAP) CHAPTER 4 - Medical Device Adverse Events and Advisory Notices Reporting.
MDSAP is a common Medical Device auditing program followed by countries like Australia, USA, Brazil, Canada and Japan. Therefore it is important for every healthcare professionals who wish to market their product in the above mentioned countries to know in detail about MDSAP.
Let's get into the topic.
CHAPTER 4 – Medical
Device Adverse
Events And Advisory
Notices Reporting
Task 1 – Notification of
Adverse Events
Task 2 – Notification of
Advisory Notices
Let’s discuss in detail
about each tasks.
Task 1 – Notification of
Adverse Events
Ensure that the medical
device organization has implemented the procedure for identifying device
related events which meets the reporting criteria set by applicable regulatory
authorities.
Ensure that the medical
device organizations procedure has special features to review the complaints to
determine whether reporting to applicable regulatory authorities is required or
not.
APPLICABLE REGULATORY
STANDARDS AND CLAUSE
ISO 13485:2016: 4.2.1,
7.2.3, 8.2.2, 8.2.3
AUSTRALIA
Therapeutic Goods
(Medical Devices) Regulations 2002 Schedule 3 Part 1 Clause 1.4(3)(c)(i).
As per Australia’s TGA,
Medical Device manufacturers are required to implement effective post marketing
system that includes provision for adverse event reporting.
The reporting timelines
as per TGA are as follows.
1. The event that represents
a serious threat to public health should be reported to regulatory authorities
within 48 hours.
2. The event that led to the
death or serious deterioration in the state of health of a patient should be
reported within 10 days.
3. The event that the
recurrence of which might lead to the death or serious deterioration in the
state of health of a patient should be reported within 30 days.
BRAZIL
RDC ANVISA 67/2009 – Art.
6º
Ensure that the medical
device organization has procedure for correct and prompt identification of
adverse events. The safety and performance of the device has to be improved
based on the results of investigation.
RDC ANVISA 67/2009 – Art.
5º
As per Brazil
regulations, Ensure that the medical device organizations top management has
appointed specific person responsible for post marketing surveillance system.
RDC ANVISA 67/2009 – Art.
8º
Ensure that the medical
device organization is reporting to the notified bodies about the adverse
events and other problems.
RDC ANVISA 67/2009 – Art.
8º
Ensure that the legal
representative in brazil for an international manufacturer is aware of the
health hazards and possibility of death while using a medical device.
CANADA
Medical Device
Regulations SOR/98-282, Section 59-61.1
Ensure that the medical
device manufacturer and importer is making a preliminary and final report to
the ministry concerning any incident happening inside or outside Canada
involving a medical device sold in Canada.
Reporting should be made
in case of failure of the device, deterioration of its efficiency and
inadequacy in labelling or instructions for use.
Reporting should be made
in case of death or serious health deterioration to user, patient or public.
As per CMDR 60 (1) (a)
(i), Ensure that the medical device organization is aware of the incident and
should report about the incident within 10 days from the date of receiving
information about the incident.
Ensure that the medical
device Manufacturer has made effective arrangements to submit preliminary
reports to the concerned Ministry and that the reports shall contain the
details as per CMDR 60 (2).
Ensure that the medical
device Manufacturer has submitted final reports to the concerned Ministry in
writing in accordance with the timetable established under CMDR 60(2)(h) and
that the reports shall contain the details as per CMDR 61 (1).
JAPAN
As per MHLW, Marketing
authorization holders are required to maintain a effective post market
surveillance system as per domestic Japanese regulatory requirements and QMS
requirements.
Ensure that the persons
operating the registered manufactured site shall reporting the adverse events coming
under PMD Act Article 228-20.2 to the marketing authorization holder as per
MHLW MO169: 62.6, instead of directly reporting to the regulatory authorities.
FDA
Ensure that the medical
device organisation has implemented procedures for reporting to FDA about
incidents involving death, serious health issues etc.
The medical device
organisation shall report to FDA within 30 days from the day, they are aware of
the incident.
Ensure that the medical
device organisations, medical device reporting (MDR) files contain information
regarding all the documents, decision making processes used to determine whether
a incident is reportable or non-reportable to FDA. Copy of all MDR forms and
all the information related to adverse events shall be submitted to FDA.
Ensure that the medical
device organisation evaluates events in accordance with the QMS requirements to
make FDA consider the submitted MDR files in compliance with 21 CFR 803.
Ensure that the MDR files
submitted to FDA contains UDI number that is printed on the device label.
The MDR files submitted
to the FDA shall be submitted electronically via the Electronic Submissions
Gateway (ESG) using eSubmitter or the AS2 Gateway-to-Gateway using HL7 ICSR XML
software.
Task 2 – Notification of
Advisory Notices
Ensure that the medical
device organisation submits the advisory notices to the regulatory authorities
within the stipulated timelines. Verify that the medical device organisation is
keeping all the records related to advisory notes and satisfying all the record
keeping requirements as per applicable regulatory bodies.
APPLICABLE REGULATORY
STANDARDS AND CLAUSE
ISO 13485:2016: 4.2.1,
7.2.3, 8.2.3, 8.3.3
AUSTRALIA (TGA)
As per Australia’s TGA,
medical device organisation shall establish a effective PMS system for recovery
of products.
TG Act 41FD
All details regarding the
recall of products shall be reported to TGA by the manufacturer or Australian
sponsor in a timely manner.
TG(MD)R Reg 5.8
Meanwhile sponsors are
required to provide all the details about conformity assessment procedure to
the manufacturer.
BRAZIL
RDC ANVISA 67/2009 - Art.
6º, RDC ANVISA 23/2012 – Art. 1º, Art. 5º
The medical device
organisation shall implement procedure to identify when field actions (recalls)
are required.
RDC ANVISA 23/2012 – Art.
4º; Art. 6º, Art. 10, Art. 11, Art. 16
Describes the record
keeping activities of medical device manufacturers.
RDC ANVISA 23/2012 – Art.
4º, Art. 6º, Art. 7º, Art. 13, Art. 14, Art. 15
In order to perform field
actions and recalls, medical device organisation shall provide evidence
justifying that their product does not comply with the requirements of safety
and effectiveness.
RDC ANVISA 67/2009 – Art.
8º
In case of international
manufacturer, the legal representative in Brazil should be aware of the recalls
performed on the devices exported to brazil by international manufacturer.
CANADA
Medical Device Regulations
SOR/98-282, Section 63 – 65.1.
The medical device
manufacturer or importer shall provide the required details on or before
undertaking a recall to the applicable ministry as per CMDR 64.
The medical device
manufacturer shall also report the results of the recall and corrective actions
taken to the applicable ministry as per CMDR 65.
In case the reports were
submitted by the importer, manufacturer shall write to the applicable ministry
stating that the manufacturer had permitted the importer to prepare and submit
the reports to the ministry as per CMDR 65.1.
JAPAN
PMD Act 68-11
The marketing
authorization holder shall report to the applicable regulatory bodies about the
advisory notices issued.
MHLW MO169: 29
The person operating the
manufacturing site does not need to directly report to regulatory authorities
about the advisory notices, whereas it is important for him to report to
marketing authorization holder so that they can communicate to regulatory
authorities.
UNITED STATES (FDA)
21 CFR 806: Medical Devices;
Reports of Corrections and Removals
Reports regarding the
recalls or corrective action shall be submitted to FDA within 10 days from the
date of initiation of recall or corrective action.
Ensure that the medical
device organisations report contains the UDI that appears on the device label
or on the device package, or the device identifier, Universal Product Code
(UPC), model, catalog, or code number of the device and manufacturing lot or
serial number of device or other identification number.
The medical device
manufacturer are supposed to maintain records of recalls even when there is no
requirement to report to FDA.
Now I hope you have acquired some knowledge about MDSAP Chapter 4 - Medical device adverse events and advisory notices reporting. We will discuss in detail about remaining chapters of Medical Device Single Audit Program in our future blogs.
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